Migraine is a common neurovascular disorder manifesting itself in attacks of headaches that can reach a level of severe pain in many patients, leading to substantial functional impairment. The recent Global Burden of Disease Study 2010 (GBD2010), conducted by the World Health Organization, estimates a worldwide prevalence of migraine of 14.7%, ranking it third place among the most common diseases, seventh place among specific causes of disability, and top among neurological disorders as cause of total years lived with disability. Migraine, thus, affects millions of people. To date, the pathophysiology of migraine is not fully understood. The current approach to migraine treatment is predominantly pharmacological.
U.S. Pat. No. 8,340,771, whose disclosure is incorporated herein by reference, describes, according to one aspect, a method of treating a patient by electrically stimulating a predetermined site to treat a neurological condition. The method includes implanting a lead into subcutaneous tissue of the C2 dermatome/C3 dermatome area.
US Patent Publication 2014/0222102, whose disclosure is incorporated herein by reference, describes an application downloadable to a mobile device for facilitating muscle therapy, the applicable programmed and configurable to generate waveform signals, the waveform signals configured to be employed by a power circuit to generate energy, conforming to the signals, to a muscle pad. The application may be combined as a system with a muscle pad electrically interfacing with the downloadable application, as well as a discrete device in electrical communication with the mobile device and the muscle pad. A power circuit and a muscle metric feedback circuit are contemplated as part of embodiments of a system or kit.
US Patent Publication 2014/0194946, whose disclosure is incorporated herein by reference, describes a TENS apparatus that includes a portable TENS device having a housing with a lower surface, a pair of integral electrodes that are incorporated in the lower surface of the housing, and a pulse driver that is located within the housing and adapted to generate a program of pulse waveforms, each of which is an asymmetrical biphasic square waveform.
U.S. Pat. No. 8,880,173, whose disclosure is incorporated herein by reference, describes a device for providing transdermal electrical stimulation at an adjustable position on a head. The device includes a supporting member economically shaped and configured to be fixedly supported about an anatomical body part; the supporting member being adjustably positionable in only two directions substantially perpendicular to one another. No electrical stimulation is provided by the supporting member. Alternatively, the device includes at least one pair of electrodes for producing the transdermal electrical stimulation to the head. The electrodes are mounted to a securing member shaped and configured to be releasably securable only about a plurality of strands of hair at a predetermined fixed orientation without being secured about any anatomical body part.
U.S. Pat. No. 8,805,548, whose disclosure is incorporated herein by reference, describes a headband for use in neurostimulation made at least partly of elastic or stretch material comprising: a hole to be located directly on the rear part of the scalp of a user, said hole being sized to fit the inion or occipital protuberantia; at least two electrodes directly attached to the headband and positioned adjacent to and symmetric about said hole, designed so that to be applied on the right and left branch of the occipital nerve respectively, once the inion is put in correspondence with said hole by the user; a connector for connecting a wearable neurostimulator to the headband, said connector being located opposite to said hole, once the headband is worn by the user and means coupled to the elastic or stretch material for electrically connecting said connector and each of said electrodes.
U.S. Pat. No. 8,428,734, whose disclosure is incorporated herein by reference, describes a device for the electrotherapeutic treatment of headaches such as tension headaches and migraines. An electrode support has a shape and is size selected so as to allow, independently from the subject, the excitation of the afferent paths of the supratrochlear and supraorbital nerves of the ophthalmic branch of the trigeminal nerve. An electrical circuit includes a programmable signal generator suitable for creating pulses of a duration of between 150 and 450 microseconds with a maximum increase in intensity of 0 to 20 milliamperes at a rate of less than or equal to 40 microamperes per second and with a step up in intensity not exceeding 50 microamperes.
U.S. Pat. No. 8,874,205, whose disclosure is incorporated herein by reference, describes a non-invasive electrical stimulation device that shapes an elongated electric field of effect that can be oriented parallel to a long nerve, such as a vagus nerve in a patient's neck, producing a desired physiological response in the patient. The stimulator comprises a source of electrical power, at least one electrode and a continuous electrically conducting medium in which the electrode(s) are in contact. The stimulation device is configured to produce a peak pulse voltage that is sufficient to produce a physiologically effective electric field in the vicinity of a target nerve, but not to substantially stimulate other nerves and muscles that lie between the vicinity of the target nerve and patient's skin. Current is passed through the electrodes in bursts of preferably five sinusoidal pulses, wherein each pulse within a burst has a duration of preferably 200 microseconds, and bursts repeat at preferably at 15-50 bursts per second.
U.S. Pat. No. 8,874,227, whose disclosure is incorporated herein by reference, describes a non-invasive electrical stimulator that shapes an elongated electric field of effect that can be oriented parallel to a long nerve, such as a vagus nerve in a patient's neck, producing a desired physiological response in the patient. The stimulator comprises a source of electrical power, at least one electrode and a continuous electrically conducting medium in contact with the electrodes. The conducting medium is also in contact with an interface element that may conform to the contour of a target body surface of the patient when the interface element is applied to that surface. When the interface element is made of insulating (dielectric) material, and disclosed stimulation waveforms are used, the power source need not supply high voltage, in order to capacitively stimulate the target nerve. The stimulator is configured to produce a peak pulse that is sufficient to produce a physiologically effective electric field in the vicinity of a target nerve, but not to substantially stimulate other nerves and muscles that lie in the vicinity of the target nerve and patient's skin.
Slavin, Konstantin V., Hrachya Nersesyan, and Christian Wess. “Peripheral neurostimulation for treatment of intractable occipital neuralgia.” Neurosurgery 58.1 (2006): 112-119, which is incorporated herein by reference, describes chronic peripheral nerve stimulation for long-term treatment of chronic pain syndrome in patients with medically intractable occipital neuralgia.
Ristic, Dejan, and Jens Ellrich. “Innocuous peripheral nerve stimulation shifts stimulus-response function of painful laser stimulation in man.” Neuromodulation: Technology at the Neural Interface 17.7 (2014): 686-695, which is incorporated herein by reference, describes electrical peripheral nerve stimulation as an effective neuromodulatory treatment in chronic pain.
Nir, Rony-Reuven, et al. “A psychophysical study of endogenous analgesia: the role of the conditioning pain in the induction and magnitude of conditioned pain modulation.” European Journal of Pain 15.5 (2011): 491-497, which is incorporated herein by reference, experimentally examines endogenous analgesia using a conditioned pain modulation paradigm.
Burstein, Rami, Michael F. Cutrer, and David Yarnitsky. “The development of cutaneous allodynia during a migraine attack clinical evidence for the sequential recruitment of spinal and supraspinal nociceptive neurons in migraine.” Brain 123.8 (2000): 1703-1709, which is incorporated herein by reference, studied the way in which cutaneous allodynia develops by measuring the pain thresholds in the head and forearms bilaterally at several time points during a migraine attack in a 42-year-old male.